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U.S. Department of Health and Human Services

Class 2 Device Recall Septodont aka Novocol

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  Class 2 Device Recall Septodont aka Novocol see related information
Date Initiated by Firm July 16, 2014
Date Posted July 29, 2014
Recall Status1 Terminated 3 on December 31, 2014
Recall Number Z-2128-2014
Recall Event ID 68794
510(K)Number K042614  
Product Classification Agent tooth bonding, resin - Product Code KLE
Product Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure
Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
Code Information Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.
Recalling Firm/
Novocol, Inc.
416 S Taylor Ave
Louisville CO 80027-3028
For Additional Information Contact Arsalan Rizvi
303-665-7535 Ext. 214
Manufacturer Reason
for Recall
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
FDA Determined
Cause 2
Process design
Action An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock.
Quantity in Commerce 60
Distribution Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KLE and Original Applicant = S & C POLYMER GMBH